QFINITY updates - publications and committee work
QFINITY · Updates

The latest from QFINITY and the field.

An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.

At a glance

Publications, committee work and more.

QFINITY beim 5. ACDM AI Symposium 2026 in London - KI in klinischen Studien und Datenmanagement

On June 23 and 24, 2026, QFINITY participated in the 5th Annual ACDM AI Symposium in London – a gathering of experts from pharmaceutical companies, CROs, and technology providers on the growing role of artificial intelligence in clinical trials and clinical data management.

QFINITY participated in the 5th Annual ACDM AI Symposium, which took place on June 23 and 24, 2026, in London. The symposium brought together experts from pharmaceutical companies, CROs, and technology providers to discuss the growing role of artificial intelligence in clinical trials and clinical data management.

Over the course of two days, experts shared practical use cases and implementation strategies and offered perspectives on the adoption of AI across the entire clinical development process. The focus was on data quality, governance, and regulatory requirements – as well as the responsible integration of AI into clinical research workflows.

For QFINITY, the symposium was an opportunity to exchange ideas with industry peers, strengthen existing partnerships, and explore how AI-supported solutions can support more efficient and compliant clinical data management.

QFINITY auf dem 5. ACDM Symposium zu KI in klinischen Studien 2026 in London

QFINITY will be attending the 5th ACDM Symposium on Artificial Intelligence in Clinical Trials (June 23-24, 2026, London) – represented by COO Marcus Schwabedissen, who will co-moderate the panel discussion “Turning AI into Impact: Real-World Applications in Clinical Data Management.”

QFINITY will be attending the 5th Annual ACDM Symposium on Artificial Intelligence in Clinical Trials, taking place on June 23-24, 2026, in London. The symposium brings together experts from pharmaceutical companies, CROs, and technology providers to discuss the current and future role of AI in clinical trials. The focus is on practical insights, real-world case studies, expert discussions, and opportunities for exchange on topics such as agentic AI, AI strategies, practical implementation experience, and the next phase of AI in clinical trials.

QFINITY will be represented by Marcus Schwabedissen, COO and Consultant at QFINITY. With his extensive experience in GxP-regulated life sciences and IT environments, computerized system validation, IT quality management, risk management, and regulatory compliance, he brings a practice-oriented perspective on the responsible and compliant use of AI-supported systems in regulated environments.

Together with Jennifer Duff and Tim Armitage, Marcus Schwabedissen will co-moderate the panel discussion “Turning AI into Impact: Real-World Applications in Clinical Data Management.” The focus is on where AI already creates real value in clinical data management today, where implementation remains challenging, and which organizational, technical, and regulatory prerequisites are needed to translate the potential of AI into measurable impact.

For QFINITY, the symposium is an important opportunity to exchange with international experts and discuss practical approaches to AI governance, validation, data integrity, and lifecycle management – and how AI can be used in regulated environments in a controlled, risk-based, and auditable way.

Beitragsaufruf ISPE Annual Meeting 2026 GAMP-Track - QFINITY

At the ISPE Europe Annual Conference 2026 in Copenhagen (April 20-22), Oliver Herrmann, Founder and CEO of QFINITY, served as Track Lead for the GAMP track „Digital Compliance by Design: GAMP, AI, data integrity and digital validation in a digitalized world“.

The life sciences industry is going through a profound digital transformation. Cloud platforms, AI-enabled tools and automation are changing how systems are built, validated and operated. These technologies open up opportunities; they also bring new risks and regulatory expectations.

At the heart of the track was the question of how „compliance by design“ works in practice: building conformity into processes, systems and technologies from the start, so that innovation can proceed without putting GxP compliance at risk. A particular focus was data integrity as the foundation for AI: without trustworthy, well-governed data, AI systems cannot perform reliably, least of all in regulated environments.

The track featured contributions on:

  • Compliance by design in practice: using AI, cloud and automation in line with GxP and regulatory requirements
  • Applying GAMP 5 Second Edition, the GAMP AI Guide and the Digital Validation Guide in digital initiatives
  • Annex 11 vs. Annex 15: where they differ and where they overlap for QA, IT and project teams
  • Data integrity in the digital age, particularly in the context of AI
  • Translating process requirements into risk-based, testable and GxP-compliant system requirements
  • Supplier qualification and continuous monitoring in outsourced or cloud environments
  • Business continuity and disaster recovery for regulated digital infrastructures

The sessions centered on case studies, lessons learned and forward-looking perspectives on emerging technologies and upcoming regulatory developments.